BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 3131138 · Received May 23, 2013

    Report

    Report Number
    1644408-2013-00288
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS DEVICE LOOSENING AFTER AN INDETERMINATE AMOUNT OF TIME IN-VIVO. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF BY THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS AND PRODUCT COMPLAINT REPORT HISTORY COULD NOT BE PERFORMED WITHOUT ADEQUATE INFORMATION REGARDING THE PART AND LOT NUMBERS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THIS INFORMATION, HOWEVER IT WAS NOT MADE AVAILABLE. THE ROOT CAUSE FOR THE DEVICE LOOSENING COULD NOT BE DETERMINED WITH CONFIDENCE. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO LOOSENING OF THE IMPLANTS. THE SURGEON REMOVED THE 56MM SHELL, 40MM HEAD, AND MP9 X-ALT LINER AND REPLACED WITH A 497-28-350 HEAD, AND CUP. THE LINER WAS REPLACED WITH A STRYKER PRODUCT. THE ORIGINAL REVELATION STEM REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228314 UNK UNK LPH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention